FDA.reportPublic FDA data

Application 022509

Type
NDA
Sponsor
SMITHKLINE BEECHAM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL25MGNoNo
002LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL50MGNoNo
003LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL100MGNoNo
004LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINENuCare Pharmaceuticals,Inc.065e97c9-3c5f-16e6-e063-6294a90a13fc2025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINEDIRECT RXa835b697-2beb-1ba8-e053-2995a90a470c2025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAdvanced Rx Pharmacy of Tennessee, LLCf7a86237-ece4-7cc4-e053-6294a90a13082024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limited44670496-41ea-36a1-c435-32e359766a742024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limitedfaee013c-cad2-4abb-904c-e6ff79ba778c2024-10-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENCS HealthCare of KY, LLC dba Vangard Labse243e803-e95f-47a6-a6da-5fed657f44622024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINENuCare Pharmaceuticals,Inc.1bbbe2a2-a9e8-8c13-e063-6394a90a96272024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepack36f383af-8b71-4875-85ef-3a7a8b1d88052024-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LPffa46cb2-16e7-45f3-9940-5cb88d0cda9d2024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LP6f7e59d2-4311-42a0-93a0-b29b0417d96f2024-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEA-S Medication Solutions5a9575bb-230e-46ae-b58e-41554bad45eb2023-11-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINEA-S Medication Solutions4e6cc1ad-55cd-4c7f-878c-fa6716e958972023-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAscend Laboratories, LLC70cd448a-2921-4c69-bdf2-5a6ce883bd072022-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEScieGen Pharmaceuticals, Inc.de700ac1-4048-467e-abb1-238953261a972022-11-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LP52273d60-3f27-4846-bf40-014ebcf094172022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LPb94ae2e4-e276-40c1-bc25-da980194fc992022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAsclemed USA, Inc.8ac9dc83-edb2-4ae5-8064-40f113fd3aab2020-10-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limitede1a0da17-d67c-e44f-bd42-33c4009e4cdd2018-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC380bddae-5b31-4965-96de-97711d859d112016-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60206ORIG2019-10-02
44764ORIG2011-02-17
22040ORIG2010-12-01
29794ORIG2010-02-17
38775ORIG2010-02-16
53309ORIG1900-01-01
53308ORIG1900-01-01